ObesePhase 1NCT06040372
A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
A Phase 1 study testing LB64640 in people with Obese and Overweight, run by LG Chem at 1 site in United States.
Trial summary
The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Overweight, Healthy
- What is being tested?
- LB64640
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2020to 30 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 to ≤ 70 years.
- Body mass index (BMI) ≥ 27 kg/m2, with stable body weight by history for 3 months (defined as change < 5%)
- HbA1c < 6.5%.
- Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
- Ability to provide written informed consent.
Who cannot join
- History or current diagnosis with T1DM or T2DM.
- History or current diagnosis of any malignancy.
- History of pheochromocytoma or insulinoma.
- History or current diagnosis of cardiac dysrhythmias or heart disease
- History of surgical treatment for obesity or any other gastrointestinal surgery
- History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder.
- Use of approved weight-lowering pharmacotherapy
- Has a clinically significant history of suicidal ideation or suicidal behavior as assessed
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Unit
Chula Vista, California, 91911
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects
The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects
Read the detailed description
The study was conducted in 2 parts:
Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6), enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.
Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7), enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once daily for 28 days with LB54640 or placebo.
- Conditions
- Obese, Overweight, Healthy
- Being tested
- LB64640, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB64640Drug
The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
PlaceboDrug
Placebo is provided as a matching placebo
| Study group | Role | What they receive |
|---|---|---|
| LB54640 | Experimental | 5 mg, 25 mg and 200 mg strengths
Subjects will be administered once daily and duration vary per each cohorts.
Single Ascending Dose (SAD) cohorts : 1 day
* SAD 1 10mg
* SAD 2 25mg
* SAD 3 50mg (Food effect cohort)
* SAD 4 100mg
* SAD 5 200mg
* SAD 6 400mg
healthy Multiple Ascending Dose (MAD) cohorts: 28days
* MAD 1 10mg
* MAD 2 25mg
* MAD 3 50mg
* MAD 4 100mg
* MAD 5 200mg
* MAD 6 400mg
* MAD 7 600mg Receives: Drug: LB64640 |
| Placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Number of subjects who experienced adverse events and severity of adverse events
Measured: Through study completion upto 6weeks depending on cohorts
Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)
Number of subjects who experienced adverse events of special interest (AESIs)
Measured: Through study completion upto 6weeks depending on cohorts
Change from baseline in vital signs (blood pressure)
Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed
Measured: Through study completion upto 6weeks depending on cohorts
Change from baseline in vital signs (heart rate)
Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))
Measured: Through study completion upto 6weeks depending on cohorts
Change from baseline in vital signs (weight in kilograms, height in meters)
weight and height will be combined to report BMI in kg/m^2
Measured: Through study completion upto 6weeks depending on cohorts
Secondary outcomes (7)
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Peak Plasma Concentration (Cmax) during the dosing periods
Measured: Through study completion upto 1week
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Area under the plasma concentration versus time curve (AUC)
Measured: Upto 1week
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Terminal half-life (t1/2)
Measured: Through study completion upto 1week during the single ascending dose cohort
Pharmacokinetics profiles in urine for single ascending dose cohort
Renal clearance (CLR)
Measured: upto 1week
Pharmacokinetics profiles in urine for single ascending dose cohort
Amount of unchanged drug excreted into urine (Ae) for specific collection intervals
Measured: Through study completion upto 1week depending on cohorts
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Maximum concentration (Cmax)
Measured: upto 2weeks
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Area under the concentration-time curve (AUC) during the dosing periods
Measured: Through study completion upto 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start16 Mar 2020
- Primary completion30 Mar 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Mirza, Principal investigator, Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040372
- Sponsor's protocol ID
- LG-MCCL001
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT06040372
- Acronym / sponsor ID
- LG-MCCL001
- Conditions
- Obese, Overweight, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects
Detailed description
The study was conducted in 2 parts:
Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6), enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.
Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7), enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once daily for 28 days with LB54640 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects
| Arm | Type | Receives |
|---|---|---|
| LB54640 | Experimental | Drug: LB646405 mg, 25 mg and 200 mg strengths Subjects will be administered once daily and duration vary per each cohorts. Single Ascending Dose (SAD) cohorts : 1 day * SAD 1 10mg * SAD 2 25mg * SAD 3 50mg (Food effect cohort) * SAD 4 100mg * SAD 5 200mg * SAD 6 400mg healthy Multiple Ascending Dose (MAD) cohorts: 28days * MAD 1 10mg * MAD 2 25mg * MAD 3 50mg * MAD 4 100mg * MAD 5 200mg * MAD 6 400mg * MAD 7 600mg |
| Placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 to ≤ 70 years.
- Body mass index (BMI) ≥ 27 kg/m2, with stable body weight by history for 3 months (defined as change < 5%)
- HbA1c < 6.5%.
- Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
- Ability to provide written informed consent.
Key exclusion criteria (8 listed)
- History or current diagnosis with T1DM or T2DM.
- History or current diagnosis of any malignancy.
- History of pheochromocytoma or insulinoma.
- History or current diagnosis of cardiac dysrhythmias or heart disease
- History of surgical treatment for obesity or any other gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB64640The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths. | Drug | LB54640 |
| PlaceboPlacebo is provided as a matching placebo | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Through study completion upto 6weeks depending on cohorts
Number of subjects who experienced adverse events and severity of adverse events
Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)
Time frame: Through study completion upto 6weeks depending on cohorts
Number of subjects who experienced adverse events of special interest (AESIs)
Change from baseline in vital signs (blood pressure)
Time frame: Through study completion upto 6weeks depending on cohorts
Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed
Change from baseline in vital signs (heart rate)
Time frame: Through study completion upto 6weeks depending on cohorts
Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))
Change from baseline in vital signs (weight in kilograms, height in meters)
Time frame: Through study completion upto 6weeks depending on cohorts
weight and height will be combined to report BMI in kg/m^2
7 secondary outcomes
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Time frame: Through study completion upto 1week
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Time frame: Upto 1week
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Time frame: Through study completion upto 1week during the single ascending dose cohort
Pharmacokinetics profiles in urine for single ascending dose cohort
Time frame: upto 1week
Pharmacokinetics profiles in urine for single ascending dose cohort
Time frame: Through study completion upto 1week depending on cohorts
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Time frame: upto 2weeks
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Time frame: Through study completion upto 2weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Mirza principal investigator
Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LB64640 in people with Obese and Overweight, run by LG Chem at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Through study completion upto 6weeks depending on cohorts). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.